Oversight Data Manager

Function

Major accountabilities:

The Senior Oversight Data manager has the following key responsibilities:

  • Direct and main responsible to deliver DM services for a study or a group of studies by leading a team of CRO resources. Manages and conducts oversight of CRO deliverables (technical & data) to ensure they are in line with the Task Order and Client expectations.
  • First point of escalation for the study teams where the Study Data Manager at the CRO is the first point of contact at a study level. Understand, mediate and solve complex issues related to DM deliverables and escalate as required.
  • Act as advisor to the Study Lead on the data management strategy from protocol to delivery of the clinical database. Provides input to study design, the clinical protocol, study planning and review of study documents. Ensures training on the protocol to the CRO resources working on the study. Responsible for managing the outsourced data management activities during the execution phase and ensuring that they are delivered as mutually agreed with the study teams. Responsible for leveraging the learnings (success or failure) after study execution to implement, in their area of responsibility, or propose, improvements for the future.
  • Provide reports, risk management plans, status updates, feedback and advice to key stakeholders on study progress. Provide input into CRO Governance, budget control and resource forecast to the Performance and Outsourcing Manager.
  • Ensure DM deliverables are in compliance with Client SOPs and regulatory guidelines.
  • Act as Subject Matter Expert in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
  • Develop and maintain excellent professional relations with the clinical teams and other key stakeholders.

Additional information

Number of indirect reports: 5-10 resources at CRO platform. These are the personnel responsible for delivery of data management activities on a study level.

The ODM is accountable for the data management aspects of study budgets and managing the Task Orders. This can amount to several million Euros. Each ODM will manage approximately 10 outsourced studies

Profile

KNOWLEDGE/EDUCATION


1. Minimum Level of Education :Bachelor Degree in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent


Why is this Level of Education Required?
The role will require understanding of complex processes and systems in the pharmaceutical industry


2. Preferred Level of Education = Master or equivalent experience
> Why is this Level of Education Preferred? Ability to apply knowledge to manage complex processes and systems in the pharmaceutical industry.

EXPERIENCE
Minimum 5 years in Clinical Research or Information Systems experience and demonstrated oversight skills
> Experience required to deliver assigned clinical data management tasks in-line with expectations in terms of time and cost and in compliance with DSCS processes . Experience required to challenge and improve the operational processes within their area of expertise

Language skills:

  • Fluent English (spoken and written)
  • French and Italian a plus

Soft skills

  • Good communication, influencing and negotiation skills within a matrix environment
  • Good problem solving and project delivery skills
  • Good networking skills

Hard skills

  • Proven ability to manage oversight of end to end outsourced processes
  • Good Project Management and Vendor Management (including risk management) skills
  • Experienced in Data Management and Clinical Systems
  • Good knowledge of global clinical trial practices, procedures, and data presentation
  • Good understanding of regulations including ICH-GCP

Contact person

M Gharbi